Alaris 800TIG2CZD1 Directions For Use Manual Download Page 1

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Alaris™ GW 800

Volumetric Pump

Directions For Use

Summary of Contents for 800TIG2CZD1

Page 1: ...s Alaris GW 800 Volumetric Pump Directions For Use en ...

Page 2: ...Getting Started 11 Initial Set Up 11 Power Input 11 Pole Clamp Installation 12 Docking Station Workstation or Equipment Rail Installation 12 Loading an Infusion Set 13 Power On Off 14 Battery Operation 14 Priming the Infusion Set 15 Automatic Set Detection 15 Starting the Infusion with a Flow Sensor Recommended 16 Standard Mode 16 Standard Mode with VTBI Time Infusion on 16 Micro Mode 16 Micro Mod...

Page 3: ...ts 28 Filter Extension Sets 29 Oncology Sets 29 Associated Products 30 The Alaris Gateway Workstation 30 The Alaris DS Docking Station 30 Maintenance 31 Routine Maintenance Procedures 31 Battery Operation 31 Disposal 31 Cleaning and Storage 32 Cleaning the Pump 32 Storing the Pump 32 Cleaning and storing the Infusion set 32 Cleaning the Flow Sensor 32 Specifications 33 IrDA RS232 and Nurse Call Sp...

Page 4: ...ng infusion rate and volume Conditions for Use The Alaris GW 800 Volumetric Pump should only be operated by medical staff competent in the use of automated volumetric pumps and in the management of infusion therapy Medical staff should determine the suitability of the device in their care area for its intended purpose w The user must be thoroughly familiar with the Pump and have been trained as pe...

Page 5: ...irections for Use and Technical Service Manual for your BD products These documents are referenced on bd com Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative An estimated delivery time will be provided when the order is placed Conventions used in this manual BOLD Used for Display names software commands controls and indicators referen...

Page 6: ...sion set Door Latch Press outer latch to open the Pump door Flow Stop Mechanism When activated the mechanism will stop fluid flow Flow Direction Label Bevel Releases the flow stop mechanism lever arm when the door is closed Keypad Display Indicators Air Sensor Pressure Sensor Mute Indicator Alarm Indicator Infra Red Communications port IrDA Folded Pole Clamp Potential Equalisation PE connector Mai...

Page 7: ...r selected infusion configuration parameters Confirms the rate during an infusion titration hf CHEVRON keys Increases or decreases the infusion rate TIME limit and VTBI Press and hold to increase the selection speed Used to adjust user selectable options Indicators when illuminated Symbol Description S AC POWER indicator When illuminated the Pump is connected to an AC power supply RATE The Pump is...

Page 8: ...irements of Council Directive 93 42 EEC as amended by 2007 47 EC T Date of Manufacture t Manufacturer Connector for Flow Sensor U Not for Municipal Waste W Fuse rating V Infusion indicator Infusing in Standard mode W Infusion indicator Infusing in Micro mode X Infusion indicator Displays fluid drops detected by the flow sensor when infusing in Standard mode Y Infusion indicator Displays fluid drop...

Page 9: ...ot be more than 1 metre above the patients heart Do not mount the Pump in a vertical position with the AC power inlet pointing upwards as this could affect electrical safety in the event of a fluid spill over the Pump Operating Pressure The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Alarm Conditions Several alarm con...

Page 10: ... is not considered an MRI compatible Pump as such If use of the Pump within an MRI environment is unavoidable then BD highly recommends securing the Pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the Pump or MRI image distortion This safe distance should be established in accordance with the manufacturers...

Page 11: ...pins of the connectors may result in ESD protection failure It is recommended that all actions must be taken by appropriately Qualified Service Personnel If this Pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or otherwise suspected to have been damaged remove it from service for inspection by Qualified Service Personnel When transporting or storing the ...

Page 12: ...ower supply for at least 2 hours to ensure that the internal battery is charged verify that the S is lit w The Pump will automatically operate from its internal battery if the Pump is switched on without being connected to the power supply Should the Pump fail to perform correctly replace in its original protective packaging where possible and contact Qualified Service Personnel for investigation ...

Page 13: ...Equipment Rail Installation Release lever Rectangular bar Rotating cam The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or equipment rails measuring 10mm by 25mm 1 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail 2 Push the pump firmly onto the rectangular bar or equipment rail 3...

Page 14: ... 273 303EV Infusion sets ensure a separation of at least 50cm is maintained between the Pump and the upper Back Check Valve 1 Close the in line clamp on the Infusion set Press the door latch to open the tubing cover door 2 Release the flow stop mechanism by pushing the lever arm up and to the right 3 Avoiding any slack insert the infusion set from left to right into the slot provided following the...

Page 15: ...s state w If the Pump alarms segments indicators do not light up correctly or 2 audible sounds are not heard then the Pump must be powered down immediately and Qualified Service Personnel contacted If transportation to an engineer is necessary it is recommended to use the original protective packaging Battery Operation The Pump will operate from the internal battery when AC Power is disconnected T...

Page 16: ...unction to fill the Infusion sets before starting an infusion Never connect the Infusion set to the patient during the priming process The prime E volume delivered will not be subtracted from the VTBI or added to the total volume infused After operating the Pump s prime function the prime function cannot be used again until after the door has been opened and closed or the Pump has been powered off...

Page 17: ...usion Standard Mode 1 Enter infusion rate using the f h keys 2 Press e button once to confirm the infusion rate 3 Enter VTBI using the f h keys or switch VTBI off by pressing the f button until OFF is displayed 4 Press e button to confirm the VTBI 5 Press m to clear VI if required 6 Press d button to start infusing Standard Mode with VTBI Time Infusion on 1 Enter VTBI using the f h keys 2 Press e ...

Page 18: ... the VTBI 5 Press m to clear VI if required 6 Press d button to start infusing Standard Mode with VTBI Time Infusion on 1 Enter VTBI using the f h keys 2 Press e button once to confirm the VTBI 3 Enter TIME using the f h keys 4 Press e button to confirm the TIME 5 Press m to clear VI if required 6 Press d button to start infusing Micro Mode 1 Enter infusion rate using the f h keys 2 Press e button...

Page 19: ...ne clamp on the secondary set 11 Press e button to scroll further or press d button to start the secondary infusion 12 Ensure the SEC Secondary indicator is lit Note The infusion rate will automatically revert to the primary infusion rate when the secondary infusion is complete On completion of the primary infusion the Pump will continue at Keep Vein Open rate KVO rate w During primary secondary i...

Page 20: ...of Scrolling between infusion parameters using the e button Muting the alarm using the m button Pausing resuming the infusion using the d button Optimising the Pumps Performance Pump performance may be optimised by moving a new section of the infusion set in the pumping mechanism To insert a new section of tubing 1 Press d to place the infusion on G 2 Ensure the in line clamp is closed 3 Open the ...

Page 21: ...with the Directions for Use Carefully read the Directions For Use supplied with the Infusion set prior to use SmartSite Needle Free System Instructions SmartSite Needle Free Valve is designed to permit safe gravity flow and automated flow injection and aspiration of fluids without the use of needles by utilising Luer lock and Luer slip connectors w Precautions Discard if packaging is not intact or...

Page 22: ...the in line clamp 7 Press the b button once and E will be displayed 8 Press and hold the b button while E is still displayed until there is no visible air in the IV line according to hospital protocol 9 Close the in line clamp 10 Attach the Infusion set to the patient 11 Open the in line clamp and restore the IV access to the patient 12 Press the d button to resume the infusion w Use aseptic techn...

Page 23: ...en PrES is displayed 2 Select HI nor or Lo using the h f keys to set the occlusion pressure level to High Normal or Low 3 Press e button to return to G or set up mode or next option Setting the Alarm Volume 1 Press e button until tonE is displayed 2 Select an alarm volume between 1 Low and 7 High using the h f keys 3 Press e button to return to G or set up mode or next option Setting a VTBI Time I...

Page 24: ...volume level 1 7 4 Enable Micro mode On OFF OFF Maximum infusion rate 1 999 ml h 999ml h Enable ASCII mode for communications On OFF OFF Enable Odd parity for communications On OFF OFF Set Pump address for communications 1 250 1 Flow Sensor Connection Mode AUTO On AUTO Set up of current time and date 00 00 to 23 59 01 01 00 to 31 12 99 N A Language selection EnGL FrAn dEut ItAL ESPA SE nEd EnGL Ir...

Page 25: ... blockage occlusion in infusion set After the tubing is properly inserted close the Pump door and resume infusion Ensure flow sensor is attached to the primary infusion set O FLOW SENSOR CONNECTION ERROR Flow sensor connected disconnected during an infusion Flow sensor is not connected and the primary VTBI is OFF Too much fluid in drip chamber Restart the infusion with the flow sensor connected di...

Page 26: ...Pump will infuse at the keep vein open rate until the d button is pressed Refer to KVO Rate section of this DFU C Bolus is being administered Release b button to return to infusion once correct bolus has been administered E The Pump is priming the Infusion set Ensure all air has been primed out of the infusion set before starting the infusion G The Pump is on hold Press d to return to infusion or ...

Page 27: ...ES Optional NO Recommended Model 180 Flow Sensor Handles Drip chamber Flanges Pull back handles Flow sensor interface Flow Sensor Interface Cover 1 Plug the flow sensor into the flow sensor interface located on the top rear part of the Pump 2 Attach the Model 180 Flow Sensor to the drip chamber of the Infusion set by pulling back the handles Refer to the illustration above 3 Proceed with load prim...

Page 28: ...273 002V Infusion set with 15µm filter in drip chamber 1 Y site and anti siphon valve 240 cm 273 003V Infusion set with 15µm filter in drip chamber 2 Y sites back check valve and anti siphon valve 240 cm 273 004V Infusion set with 15µm filter in drip chamber roller clamp and Luer back check valve 220 cm Suitable for gravity infusion 273 005V Infusion set with roller clamp and a back check valve 22...

Page 29: ...urette set with 1 SmartSite Valve Y port and anti siphon valve 230 cm Opaque Sets 273 043V Light Resistant PVC infusion set with anti siphon valve and Pump segment with 15µm filter in drip chamber 250 cm Low Sorbing Sets 273 053V Low Sorbing PVC infusion set with anti siphon valve and Pump segment with 15µm filter in drip chamber 270 cm Secondary Sets 72213 0006 Secondary Piggyback set with 18G ne...

Page 30: ...on set with 0 2µm filter and one SmartSite Valve Y port Rotating male Luer lock approx 51 cm Low Sorbing Polyethylene Lined Oncology Sets MFX273 950E Oncology set with five SmartSite Valve Y ports 265 cm MFX273 951E Oncology set with three SmartSite Valve Y ports 261 cm MFX273 952E Amber Oncology set with five SmartSite Valve Y ports 265 cm MFX273 954E Amber Oncology set with three SmartSite Valve...

Page 31: ...A Maximum Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115 230V 50 60Hz 60VA The Alaris DS Docking Station Product SKU 80283UNS00 xx Supply Voltage 230VAC 50 60Hz Electrical Rating 500VA nominal Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 20VA max 230V 50 60Hz y Connectivity option 1 2 or 3 xx Conf...

Page 32: ...ows continued operation when the AC power is unavailable for example during patient transfer or AC power failure The infusion time on battery is rate dependant see Specifications section of the DFU From the battery low alarm it will take about 24 hours to fully recharge when reconnected to the AC power supply whether the Pump is in use or not The battery is automatically charged during AC operatio...

Page 33: ...as these may damage the exterior surface of the Pump Do not steam autoclave ethylene oxide sterilise or immerse this Pump in any fluid Storing the Pump If the Pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Once every 3 mont...

Page 34: ...ctory It is not recommended that the proof strength test is reapplied if the Pump is tested again during service Classification Class I Equipment Continuous Portable Equipment type 4 AC Power Supply 220 240 VAC 50 60Hz 10VA nominal Protection against fluid ingress IP32 Protected against direct sprays of water up to 15 from vertical and protected against solid objects greater than 2 5mm Dimensions ...

Page 35: ... to 99 hours and 59 mins Memory Retention The electronic memory of the Pump will be retained for at least 6 months when not powered up Minimum Occlusion Alarm Pressure 100mmHg Maximum Occlusion Alarm Pressure 1000mmHg Bolus volume generated at 25 0 ml h when the minimum occlusion alarm threshold is reached 0 3ml Bolus volume generated at 25 0 ml h when the maximum occlusion alarm threshold is reac...

Page 36: ...ge x 40 mm Solution Type De ionized Degassed Water Temperature 23 2 C Fluid Head Height 0 3 0 1 m Back Pressure 0 10 mmHg 3 All are as normal conditions with the following additions Set Rate 1 to 999 ml h Solution Type All fluids4 Temperature 5 C 40 C Fluid Head Height 0 1 0 m 4 Tested using Distilled water 20 lipid 50 glucose 0 9 Normal Saline and 5 Alcohol solutions 5 Whichever is the greater of...

Page 37: ...The assessment for the suitability of any software used in the clinical environment to control or receive data from the Pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Technical Service Manual and is for general information only Any connected analogue and digital components are ...

Page 38: ...s are derived from the second hour of this data Tests performed per IEC60601 2 24 standard Start up Graph at 1 0ml h Initial Period 273 001 Infusion Set Start up Graph at 25 0ml h Initial Period 273 001 Infusion Set Flow Rate ml h Start up Graph at 1 0 ml h Initial Period 0 2 0 0 0 2 0 4 0 6 0 8 1 0 1 2 1 4 1 6 1 8 2 0 0 10 20 30 40 50 60 70 80 90 100 110 120 Time minutes Flow ml h Flow Rate ml h ...

Page 39: ...eline pressure measurement The Pump takes a reference pressure from the IV line when the infusion commences and alarms at a preset limit above the baseline pressure The pressure alarm limits are 250 350 and 500 mmHg above the baseline pressure corresponding to the low normal or high pressure limits To avoid excessively large pressures the Pump is capped at 1000 mmHg Upstream Occlusion Pressure To ...

Page 40: ...able in electronic format on the World Wide Web at bd com int alaris technical A username and password are required to access our manuals Please contact a local customer services representative to obtain login details Part Number Description 1000EL00349 Internal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European Document History Issue Date Software Version Description 1 J...

Page 41: ...e Alaris bd com Hungary 36 1 488 0233 info cfn export bd com Italy 39 0 55 303391 customer service italy bd com Netherlands 31 0 30 2289 704 31 0 30 2289 711 info alaris nl bd com New Zealand Freephone 0508 422 734 64 92702420 NZ CustomerService carefusion com Norway 47 64 00 99 00 bdnorge bd com Poland 48 22 545 05 80 dok medicart eu Portugal 351 219 152 593 dl pt geral carefusion com South Afric...

Page 42: ...s proprietary information of Becton Dickinson and Company or one of its affiliates and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of Becton Dickinson and Company or one of its affiliates is strictly forbidden B...

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